临床试验/NCT01192659

NCT01192659已完成不适用

Identification of Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes: An Analysis of Data From the SAVOR Study

AstraZeneca0 个研究点目标入组 16,492 人开始时间: 2010年5月最近更新: 2016年12月1日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: AstraZeneca
入组人数: 16,492
主要终点: To identify risk factors for lymphopenia, defined as an absolute lymphocyte count < 500 cells/μl, or investigator reported lymphopenia, in the SAVOR study population.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to identify risk factors for low lymphocyte count among patients with type 2 diabetes who are treated with oral antidiabetic drugs.

详细描述

Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Enrolled in SAVOR
•Diagnosed with T2DM
•Baseline HbA1c ≥6.5% (based on the last measured and documented laboratory measurement within 6 months)
•Age 40 or older
•High risk for a cardiovascular event

排除标准

•Not enrolled in SAVOR
•Current or previous treatment with DPP4 inhibitors and/or GLP-1 or incretin mimetics.
•Acute vascular event
•Pregnancy
•Severe autoimmune disease
•Current chronic steroid use

结局指标

主要结局

To identify risk factors for lymphopenia, defined as an absolute lymphocyte count < 500 cells/μl, or investigator reported lymphopenia, in the SAVOR study population.

时间窗: 60 months

次要结局

To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users.(60 months)
To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline.(60 months)
To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia.(60 months)

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

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